MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Twitching (2172)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Patient reported feeling stimulation that would cause her arm to contract.The patient had their device checked and the impedance was within normal limits.The surgeon then decided to do a full revision but the products will not be returned.No other relevant information has been received to date.

Event Description

Information was obtained which indicated that per the physician's assessment the cause of the patient arm contracting was related to vns stimulation.The full revision was related to the arm contraction but it was for patient comfort only.

Manufacturer Narrative

Describe event or problem , corrected data: initial report inadvertently did not provide the physician's assessment of the event.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11825023
• MDR Text Key: 250817250
• Report Number: 1644487-2021-00651
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2016
• Device Model Number: 102R
• Device Lot Number: 202882
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/22/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR